Hannah Clarke

“The majority (76%) of patients not yet meeting the Phoenix criteria did have PSMA-avid lesions on PSMA-PET, suggesting [prostate cancer] recurrence," says Evelien J E van Altena.

The phase 3 ENVISION trial met its primary end point by demonstrating a 79.6% complete response rate at 3 months following the first instillation of the therapy.

“These findings support the safety of vaginal estrogen for treatment of local menopause symptoms, even in high-risk women,” says Gabriella M. Rustia, MD.

The approval is supported by data from the phase 3 SURE 1 and REASSURE trials.

The therapeutic response rate was 79% at 24 months, which is comparable to the rates seen at 6 months (78%) and 12 months (82%).

At 1 month, the mean decrease in the OAB-Q symptom severity subscale score was -31.2 in the 1-injection cohort vs -39.5 in the 10-injection cohort.

Patients with higher baseline HEI and E-HEI scores were less likely to experience grade reclassification.

The cystoscopy solution was granted a CE mark for regulatory clearance in Europe in October 2023.

The trial is comparing the diagnostic performance of 61Cu-NODAGA-PSMA I&T with that of 18F-piflufolastat.

The codes will go into effect on January 1, 2026.

None of the videos mentioned the long-term impact of exogenous testosterone on spermatogenesis.

The decision to withdraw sacituzumab govitecan from the market was made in consultation with the US FDA following negative data from the phase 3 TROPiCS-04 trial.

Almost all studies (93.5%) reported an improvement in validated patient-reported outcomes following treatment.

Overall, 4 of 5 patients with low-grade disease who received bel-sar with light activation achieved a complete clinical response.

At 5 years, 95.8% of patients in the SBRT arm were free from biochemical or clinical failure compared with 94.6% of patients in the control radiotherapy arm.

Data from the EMPIRE-2 trial also showed that 18F-fluciclovine resulted in significantly more boosts to the prostate bed.

The target action date for the application is June 13, 2025.

Overall, 15/16 patients had a true positive scan based on confirmatory imaging and/or biopsy, equating to a PPV of 93.75%.

The application is supported by data from the pivotal phase 3 ARANOTE trial.

Patient recruitment for the phase 3 AMPLIFY trial is set to begin early next year.

Both 177Lu-PSMA-I&T and 64Cu-PSMA-I&T are currently in phase 3 development for use in prostate cancer diagnostics and treatment.

“Nivolumab, combined with standard of care trimodality therapy, appears to be promising for the treatment of grade group 5 prostate cancer," says John Michael Bryant, MD.

“While there are other treatment options available for treating BPH, there remains a significant need for much less invasive treatment approaches that can preserve and protect the integrity of the urethra and other critical structures," says Ryan Rhodes.

"Overall, TAR-200 is being tested with the aim of changing the therapeutic paradigm of patients with an early bladder cancer diagnosis, including non–muscle-invasive disease and muscle-invasive disease," says Andrea Necchi, MD.

"We remain on track for the opening of phase 2 in the next few months. We also expect to see the full phase 1 results presented at a scientific meeting in 2025," says David E. Gauden, DPhil.

Patients with elevated CTC count at baseline experienced poor complete response rates and worsened PFS and OS.

The WATER IV PCa will assess Aquablation vs radical prostatectomy in patients with grade group 1 to 3 localized prostate cancer.

Illuccix is now indicated for use in the selection of patients with mCRPC for PSMA-targeted radionuclide therapy.

“We are pleased that a first patient has been imaged in the CA-NINE trial, which supports potential label expansion for TLX250-CDx into recurrent, metastatic disease,” says David N. Cade.

The overall report rate per unit sold of the PEG hydrogel spacers was 0.40%.